Protein characterization

Comprehensive analysis of your protein-based product

Do you need customized protein characterization, e.g. identification, quantification and sequencing of your biopharmaceutical protein and its product-related impurities?

Or are you are looking to analyze process-related impurities, e.g. Host Cell Proteins (HCPs) throughout your purification steps and in clinical GMP-batches?

With our mass ...

Do you need customized protein characterization, e.g. identification, quantification and sequencing of your biopharmaceutical protein and its product-related impurities?

Or are you are looking to analyze process-related impurities, e.g. Host Cell Proteins (HCPs) throughout your purification steps and in clinical GMP-batches?

With our mass spectrometry-based analyses, you can…

  • Confirm your protein sequence and find sequence variants and degradation products. Analyze protein stability and quantify modifications
  • Find the HCP ELISA with highest coverage for your drug and process HCPs
  • Identity and quantity of all individual proteins in your samples, including residual HCPs

Alphalyse protein services are optimized for a wide range of protein-based biologics. With experience from thousands of analytical runs and more than 100 HCP analysis projects, we are a an experienced protein characterization CRO, with an established and validated workflow for most expression systems and sample types.

Standard or customized analysis

The analyses can be customized to fit your specific protein product, with the aim to strengthen your process development and production throughout the project. You can choose and combine your preferred analysis package from the services below or send us your project description so we can design an analysis package that meets your needs.

We conduct all protein analyses according to the ICH Q6B guidelines – Test Procedures and Acceptance Criteria for Biotechnological/Biological Products. All repetitive tasks are automated to ensure high reproducibility and fast reporting time.

You can go with one or combine several analyses from the list below, depending on your project needs.

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More info

Protein characterization is crucial in both research and process development of biologics, before research can be validated and pharmaceutical products can reach clinical administration. Therefore, experience and knowledge of analytical approaches must be of the highest quality to ensure thorough protein characterization. After offering protein analysis for more than 15 years, we have investigated and detected millions of proteins.

Both the Alphalyse founders and several employees share a close relation to the Protein Research Group at the University of Southern Denmark (SDU), known all over the world for its advances within protein science. Together with the newest instruments on the market, this ensures that we are a world leading Protein Characterization CRO.

We are heavily experienced working with characterization of recombinant proteins, such as enzymes, hormones and growth factors, as well as their derivatives and relatives, e.g. host cell proteins (HCPs), peptide fragments and proteases.

Typically, several analyses are combined for complete characterization of proteins by their size, structure and physiochemical properties. For batch release testing, it could include intact mass and peptide fragmentation analysis, characterization of post translational modifications, sequence verification and analysis of impurities, both process- and product-related.

Who is this for?

We primarily help customers within the pharmaceutical industry, and biotechs working on drug development, e.g.

Project managers

Working with process development and characterization projects.

Analytical experts

Protein scientists that work with elisa, masss spectrometry, or CMC.

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